Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia

Summary

The purpose of this study is to better understand the anti-inflammatory benefits of two
prescription medicines that are currently used to help people with cholesterol problems.

Fish oil, from eating certain kinds of fish and from supplement pills, has been used to help
control cholesterol and reduce inflammation (the body's response to injury or sickness).
Lovaza® is the brand name for prescription strength fish oil pills. In this study, we will
be looking at how Lovaza® works to help reduce inflammation in healthy volunteers.

Tricor® is the brand name for prescription fenofibrate pills. Fenofibrate is a prescription
medicine that many doctors give to people with high triglyceride (fat in the blood) levels.
In this study, we will be looking at how Tricor® works to help reduce inflammation in
healthy volunteers.

Endotoxin or lipopolysaccharide (LPS) is a small part of bacteria (that is no longer living)
that can cause many of the effects similar to bacterial infections in humans. However, it
can be administered in very small amounts to produce a mild immune response much the same as
a 'flu' like illness. Within 1 ½ -3 hours after giving LPS by vein, a response consisting
of fever, chills, headache, nausea and vomiting and generalized aches and pains will occur
which lasts up to 6-8 hours. In addition to the flu like symptoms, the response causes
temporary changes in cholesterol, triglycerides and blood sugar. Different people respond
differently to LPS. We are using LPS in this study to bring on a temporary inflammatory
response in the body and to compare the responses of people who receive Lovaza® or Tricor®
to the responses of people who receive a placebo (pill that does not contain medicine).

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Medical and Biotech [MESH] Definitions

Tablets, Enteric-coated

Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)

Pregnancy Complications, Cardiovascular

The co-occurrence of pregnancy and a cardiovascular disease. The disease may precede or follow FERTILIZATION and it may or may not have a deleterious effect on the pregnant woman or FETUS.

Cardiac Rehabilitation

Restoration of functions to the maximum degree possible in a person or persons suffering from a CARDIOVASCULAR DISEASE. It also includes cardiac conditioning and SECONDARY PREVENTION in patients with elevated cardiovascular risk profile.

Fenofibrate

An antilipemic agent which reduces both CHOLESTEROL and TRIGLYCERIDES in the blood.

Therapeutic Misconception

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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